FDA 483 - Steven H. Dayan, MD - October 06, 2023

An FDA inspection of Steven H. Dayan, M.D., Clinical Investigator, revealed significant deficiencies in study documentation. The firm failed to properly document informed consent, as subjects did not sign and date consent forms prior to receiving investigational medical devices. Additionally, subject case histories were incomplete, with concomitant medications and medical/surgical histories not fully captured in the electronic case report forms.